A method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface

Abstract

The present invention provides a method for manufacturing a catheter body with a shark pattern microstructure on the surface, comprising: S1, making a core rod and a hot pressing mold with a shark pattern microstructure, the hot pressing mold is in a hollow cylindrical shape, and the inner surface of the hot pressing mold has a shark pattern microstructure; S2, coating the surface of the core rod in step S1; S3, placing the core rod with the coating into the hot pressing mold, and transferring the shark pattern microstructure to the coating through high temperature and high pressure; S5, after the transfer is completed, the coating is solidified to form a tube body, the tube body is taken out of the hot pressing mold, and the core rod is separated from the tube body; the catheter body with a shark pattern microstructure can be obtained. Using the manufacturing method of the present invention, since a shark pattern microstructure is added to the catheter body, the catheter has an antibacterial effect when inserted into the human body for drainage, thereby improving the safety of use; it also has the functions of preventing tissue adhesion and alleviating user pain, thereby solving the problem of poor comfort during use.

Description

Technical Field

[0001] The invention relates to the field of preparation of urinary catheters, and in particular to a method for manufacturing a urinary catheter body with a shark pattern microstructure on the surface. Background Art

[0002] A urinary catheter is a long, thin tube made of high-grade medical materials such as silicone rubber or polyvinyl chloride. It is usually about 40 to 50 cm long and has a closed end for easy connection to a drainage bag. A urinary catheter is mainly used to drain urine from the bladder to the body. It is often used for patients with dysuria, long-term coma, critically ill patients, and urinary retention. It can help doctors diagnose and treat certain diseases, such as urinary tract infections and prostate hyperplasia.

[0003] Traditional urinary catheters are usually accompanied by urinary tract infections and discomfort when used. There are some solutions on the market that alleviate the above problems by adding chemical coatings, but they are not satisfactory in terms of safety and effectiveness. Therefore, a urinary catheter with higher safety and better comfort and a manufacturing method thereof are urgently needed. Summary of the invention

[0004] To this end, the present invention provides a method for manufacturing a catheter body having a shark pattern microstructure on the surface. The catheter using the catheter body manufactured by the manufacturing method is used to solve the technical problems of low safety and poor comfort of existing catheters during use.

[0005] The present invention provides the following technical solution: a method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface, comprising the following manufacturing steps:

[0006] S1, manufacturing a core rod and a hot pressing mold with a shark pattern microstructure, wherein the hot pressing mold is in a hollow cylindrical shape, and an inner surface of the hot pressing mold has a shark pattern microstructure;

[0007] S2, coating the surface of the mandrel in step S1;

[0008] S3, placing the core rod with the coating in step S2 into the hot pressing mold in step S1, and transferring the shark pattern microstructure to the coating in step S2 through high temperature and high pressure;

[0009] S4, after the transfer is completed, the coating is solidified to form a tube body, the tube body is taken out from the hot pressing mold, and the mandrel is separated from the tube body;

[0010] That is, a urinary catheter body with a shark pattern microstructure can be obtained.

[0011] Preferably, the step S1 of making a hot pressing mold with a shark pattern microstructure further comprises the following steps:

[0012] S11-1, preparing a soft film having a shark-grain microstructure on one side;

[0013] S11-2, preparing a mold base, wherein the mold base has a semi-cylindrical protrusion arranged longitudinally;

[0014] S11-3, attaching the smooth side of the soft film having the shark pattern microstructure to the surface of the mold base;

[0015] S11-4, uniformly forming a metal conductive layer with a thickness of 30-300 nm on the side of the soft film having the shark pattern microstructure;

[0016] S11-5, thickening the metal conductive layer generated in step S11-4 to 3 mm-20 mm;

[0017] S11-6, peeling off the metal conductive layer thickened in step S11-5 from the surface of the soft film attached to the surface of the mold base, removing the excess part required for manufacturing the hot pressing mold, and obtaining a half part of the hot pressing mold with a shark pattern microstructure on the inner surface;

[0018] S11-7, repeating steps S11-1 to S11-6 to obtain the other half of the hot pressing mold having a shark pattern microstructure on the inner surface;

[0019] By combining the two parts of the hot pressing molds with shark pattern microstructures on the inner surfaces in steps S11-6 and S11-7, a complete hot pressing mold with shark pattern microstructures can be obtained.

[0020] Preferably, the step S11-3 also includes an exhaust treatment process so that the smooth side of the soft film with shark pattern microstructure is tightly attached to the surface of the mold base, and the exhaust treatment process uses an electrostatic adsorption method, a vacuum adsorption method, an adhesive bonding method, or a substrate hardening method.

[0021] Preferably, when the core rod prepared in step S1 is a core rod having a shark pattern microstructure, the method further includes the following steps:

[0022] S12-1, preparing a core rod body, wherein the core rod body has a cylindrical structure;

[0023] S12-2, coating an adhesion-promoting layer on the outer peripheral surface of the mandrel;

[0024] S12-3, providing a carrier with a shark pattern microstructure on the surface of the adhesion-promoting layer;

[0025] S12-4, attaching the shark grain microstructured side of the soft film to the surface of the carrier, and curing the soft film to cure the adhesion-promoting layer and the carrier on the mandrel body, so that the carrier, the adhesion-promoting layer and the mandrel body form a combined body;

[0026] S12-5, peeling off the soft film, and transferring the shark pattern microstructure of the soft film to the combined body;

[0027] That is, a core rod with a shark pattern microstructure can be obtained.

[0028] Preferably, in the step S12-2, the adhesion-promoting layer is evenly coated on the core rod body by spraying or curtain coating.

[0029] Preferably, in step S12-2, the material of the adhesion-enhancing layer is one or more of rosin resin, polyterpene resin, petroleum resin, and phenolic resin, and the thickness is 10-40 um.

[0030] Preferably, in step S12-3, the material of the carrier is resin or latex, and the thickness is 10-30 um.

[0031] Preferably, in step S12-4, the shark pattern microstructure is evenly or unevenly distributed on the entire or partial surface of the carrier.

[0032] Preferably, in step S12-4, the curing method is baking curing or UV curing, the baking includes baking at 60-90°C for 3 minutes to 10 minutes, and the UV curing process is curing by a UV lamp with an energy of 100-500mJ.

[0033] The present invention further provides a urinary catheter, comprising a urinary catheter body, wherein the urinary catheter body is manufactured by the manufacturing method of the urinary catheter body having a shark pattern microstructure on the surface.

[0034] Beneficial effects:

[0035] The present invention provides a method for manufacturing a urinary catheter body with a shark pattern microstructure on the surface. The method comprises the following steps: manufacturing a core rod and a hot pressing mold with the shark pattern microstructure, placing the core rod with a coating into the hot pressing mold with the shark pattern microstructure, transferring the shark pattern microstructure to the coating coated on the core rod through high temperature and high pressure, and separating the coating from the hot pressing mold and the core rod after solidification to form a urinary catheter body with the shark pattern microstructure.

[0036] The use of a urinary catheter having a shark pattern microstructure manufactured by the manufacturing method provided by the present invention has an additional layer of shark pattern microstructure on the surface of the urinary catheter body, so that the urinary catheter has an antibacterial effect when inserted into the human body for drainage, thereby improving the safety of use; it also has the functions of preventing tissue adhesion and alleviating the pain of the user, thereby solving the problem of poor comfort during use.

[0037] When the core rod used is a core rod with a shark pattern microstructure, a layer of shark pattern microstructure is added to the surface and inner cavity of the catheter body, that is, by adding a layer of micron-level antibacterial texture on the inside and outside of the catheter body, a catheter body with a shark pattern microstructure on both sides is formed, which overcomes the technical difficulties of double-sided transfer of microstructures on a small tube structure in the traditional transfer process and further enhances the antibacterial effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to make the contents of the present invention more clearly understood, the present invention is further described in detail below based on specific embodiments of the present invention in conjunction with the accompanying drawings.

[0039] Figure 1 Schematic diagram of the shark grain microtexture structure of the soft film with shark grain microstructure in Example 1 of the present invention;

[0040] Figure 2 This is a schematic diagram of the mold base in step S1 of the manufacturing method of Example 1 of the present invention;

[0041] Figure 3 A cross-sectional view of a urinary catheter body having a shark pattern microstructure manufactured by the manufacturing method of Example 1 of the present invention;

[0042] Figure 4 This is a physical picture of a urinary catheter having a urinary catheter body with a shark pattern microstructure manufactured by the manufacturing method provided by the present invention. DETAILED DESCRIPTION

[0043] In order to explain the technical content, achieved objectives and effects of the present invention in detail, the following is an explanation in conjunction with the implementation modes.

[0044] Example 1

[0045] The present invention provides a method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface, comprising the following manufacturing steps:

[0046] S1, manufacturing a core rod and a hot pressing mold with a shark pattern microstructure, wherein the hot pressing mold is in a hollow cylindrical shape, and an inner surface of the hot pressing mold has a shark pattern microstructure;

[0047] S11-1, preparing a soft film having a shark-grain microstructure on one side;

[0048] like Figure 1As shown, the structural features of the shark pattern microstructure of the soft film are a*b*c SK / ISK, where a is the width of the shark pattern microstructure, b is the gap between adjacent shark pattern microstructures, c is the height / depth of the shark pattern microstructure, SK refers to a protruding microstructure, and ISK refers to a concave structure. Wherein, a is 1 micron-100 microns, b is 1 micron-100 microns, and c is 1 micron-100 microns. The structural features of the shark pattern microstructure include but are not limited to 2*2*3SK / ISK, 5*3*4SK / ISK or 10*5*4SK / ISK. Preferably, each shark pattern microstructure has the same or different structural features.

[0049] S11-2, preparing a mold base, wherein the mold base has a semi-cylindrical protrusion arranged longitudinally;

[0050] The prepared mold base is divided into three models, and the manufactured hot pressing molds are used to manufacture three models of catheter tube bodies. The first model of mold base can be used to manufacture the first model of hot pressing mold, which is used to produce small catheter tube bodies with outer diameters between 4Fr and 6Fr, which are suitable for children or adults with smaller bodies; the second model of mold base can be used to manufacture the second model of hot pressing mold, which is used to produce medium-sized catheter tube bodies with outer diameters between 8Fr and 12Fr, which are suitable for most adult men and women; the third model of mold base can be used to manufacture the third model of hot pressing mold, which is used to produce large catheter tube bodies with outer diameters between 14Fr and 20Fr, which are suitable for patients who need larger drainage channels, such as patients with enlarged prostate or urethral stenosis.

[0051] The mold base can be made of metal (such as stainless steel, aluminum alloy), plastic (such as ABS, polycarbonate) or a composite material. The mold base has a semi-cylindrical protrusion in the longitudinal middle portion, which is used to form an inner cavity space for manufacturing the finished hot pressing mold.

[0052] S11-3, attaching the smooth side of the soft film with shark pattern microstructure to the surface of the mold base;

[0053] Specifically, the material of the soft film with shark pattern microstructure can be ABS, silicone, polyvinyl chloride (PVC) and other soft polymer materials. If gaps or bubbles are generated when the soft film with shark pattern microstructure is fitted with the mold base, the soft film will be twisted or wrinkled, directly affecting the effect of subsequent electrochemical deposition or physical vapor deposition to generate a metal conductive layer, and further affecting the shape and structure of the catheter body.

[0054] In order to ensure that the smooth side of the soft film with shark pattern microstructure can be closely attached to the mold base and eliminate the influence of gaps and bubbles, step S11-3 also includes an exhaust treatment process, which can be applied by electrostatic adsorption method, vacuum adsorption method, adhesive bonding method or substrate hardening method to closely attach the smooth side of the soft film with shark pattern microstructure to the mold base. Figure 2 As shown, when the vacuum adsorption method is used, specifically, a plurality of through holes can be opened on the surface of the mold base, and after the smooth side of the soft film with the shark pattern microstructure is attached to one side of the mold base, a negative pressure environment is created on the other side of the mold base using the vacuum adsorption method. Suction is generated on the soft film with the shark pattern microstructure through the plurality of through holes opened in the mold base, so that the soft film with the shark pattern microstructure can be tightly attached to the mold base.

[0055] S11-4, uniformly forming a metal conductive layer with a thickness of 30-300 nm on the surface of the side of the soft film having the shark pattern microstructure;

[0056] Specifically, the method of generating the metal conductive layer can be implemented by electrochemical deposition or physical vapor deposition. Since the structural features of the shark grain microstructure of the soft film are at the micron level, by using the electrochemical deposition method, the deposition process of the material can be controlled at the microscopic level, thereby achieving high-precision mold manufacturing. The electrochemical deposition method is particularly suitable for manufacturing molds with complex geometric shapes and fine structures, such as micro channels, grooves and holes. By accurately controlling parameters such as current density, solution composition and deposition time, the shape and size of the mold with shark grain texture mechanism required by the present invention can be obtained.

[0057] At the same time, during the electrochemical deposition process, the material is gradually deposited on the substrate in the form of atoms or ions to form a dense and uniform coating. This deposition method avoids the problems of cutting marks, burrs and stress concentration that may occur in traditional mechanical processing, thereby obtaining high-quality surface finish and flatness.

[0058] S11-5, thickening the metal conductive layer in step S11-4 to 3 mm-20 mm;

[0059] Specifically, the metal conductive layer may be thickened by electrochemical deposition, and the thickened metal conductive layer comprises half of the hot pressing mold to be manufactured.

[0060] S11-6, peeling off the metal conductive layer thickened in step S11-5 from the surface of the soft film attached to the surface of the mold base, removing the excess part required for manufacturing the hot pressing mold, and obtaining a half part of the hot pressing mold with a shark pattern microstructure on the inner surface;

[0061] S11-7, repeating steps S11-1 to S11-6 to obtain the other half of the hot pressing mold having a shark pattern microstructure on the inner surface;

[0062] By combining the two parts of the hot pressing molds with shark pattern microstructures on the inner surfaces in steps S11-6 and S11-7, a complete hot pressing mold with shark pattern microstructures can be obtained.

[0063] When the core rod prepared in step S1 is a core rod having a shark pattern microstructure, the following steps are also included:

[0064] S12-1, preparing a core rod body, wherein the core rod body has a cylindrical structure;

[0065] Specifically, the core rod body can be made of ceramic or metal. The core rod body includes a cylindrical core and a cylindrical core with a notch. The cross-sections of the cylindrical core and the cylindrical core with a notch are as follows: Figure 3 As shown; in a specific embodiment, the core rod body can also be an independent cylindrical core rod. The core rod body is designed to be divided into three models. The first model of the core rod body can match the first model of the mold base in step S11-2, and is used to produce a small catheter body with an outer diameter between 4Fr and 6Fr, which is suitable for children or small adults; the second model of the core rod body can match the second model of the mold base in step S11-2, and is used to produce a medium-sized catheter body with an outer diameter between 8Fr and 12Fr, which is suitable for most adult men and women; the third model of the core rod body can match the third model of the mold base in S11-2, and is used to produce a large-sized catheter body with an outer diameter between 14Fr and 20Fr, which is suitable for patients who need a larger drainage channel, such as patients with prostatic hypertrophy or urethral stenosis.

[0066] S12-2, coating an adhesion-promoting layer on the outer peripheral surface of the core rod;

[0067] Specifically, the adhesion layer can be evenly coated on the outer peripheral surface of the core rod body by spraying or pouring. The material of the adhesion layer can be one or more of rosin resin, polyterpene resin, petroleum resin, phenolic resin, or other silicone resin, epoxy resin, polyurethane, acrylate, fluorocarbon coating or composite coating, and the thickness of the adhesion layer can be 10-40um.

[0068] S12-3, adding a carrier with shark pattern microstructure on the surface of the adhesion-promoting layer;

[0069] Specifically, the shark pattern microstructure carrier can be evenly coated on the adhesion-enhancing layer by spraying or pouring, the material of the carrier is resin or latex, and the thickness of the carrier is 10-30 um.

[0070] S12-4, attaching the shark grain microstructured side of the soft film to the surface of the carrier, and curing the soft film to cure the adhesion-promoting layer and the carrier on the core rod body, so that the carrier, the adhesion-promoting layer and the core rod body form a combined body;

[0071] Specifically, the shark pattern microstructure is evenly or unevenly distributed on the whole or part of the surface of the carrier. It can be cured by baking or UV curing, the baking curing includes baking at 60-90°C for 3 minutes to 10 minutes, and the UV curing process is cured by UV lamp with 100-500mJ energy.

[0072] S12-5, peeling off the soft film, and transferring the shark pattern microstructure of the soft film to the combined body;

[0073] The mandrel with shark pattern microstructure

[0074] S2, coating the surface of the core rod in step S1;

[0075] Specifically, the core rod in step S1 is coated with a coating by using an extruder. The material of the coating may be silicone or polyvinyl chloride (PVC) and the like. The coating may be evenly coated on the core rod.

[0076] S3, placing the core rod with the coating in step S2 into the hot pressing mold in step S1, and transferring the shark pattern microstructure to the coating in step S2 through high temperature and high pressure;

[0077] Specifically, when the mandrel is an ordinary mandrel, only the shark pattern microstructure of the hot pressing mold is transferred to the coating in step 2, and finally a catheter body with a single-sided shark pattern microstructure on the outer surface is formed; when the mandrel is a mandrel with a shark pattern microstructure, the shark pattern microstructures of the hot pressing mold and the mandrel with the shark pattern microstructure are transferred to the inner and outer surfaces of the coating in step 2, and finally a catheter body with double-sided shark pattern microstructures on the inner and outer surfaces is formed.

[0078] According to the different choices of hot pressing mold materials, different high temperature ranges and high pressure ranges are used.

[0079] S4, after the transfer is completed, the coating is solidified to form a tube body, the tube body is taken out from the hot pressing mold, and the mandrel is separated from the tube body;

[0080] That is, a urinary catheter body with a shark pattern microstructure can be obtained.

[0081] Example 2

[0082] like Figure 4 As shown, the present invention further provides a urinary catheter, including a urinary catheter body, and the urinary catheter body is manufactured by the above-mentioned manufacturing method of the urinary catheter body with shark pattern microstructure on the surface.

[0083] It should be noted that the manufacturing process provided by the present invention is not limited to manufacturing a urinary catheter tube body with a shark pattern microstructure, but can also be applied to the processing and manufacturing of other medical products with a tube body containing a shark pattern microstructure.

[0084] The present invention provides a method for manufacturing a urinary catheter body with a shark pattern microstructure on the surface. The method comprises the following steps: manufacturing a core rod and a hot pressing mold with the shark pattern microstructure, placing the core rod with a coating into the hot pressing mold with the shark pattern microstructure, transferring the shark pattern microstructure to the coating coated on the core rod through high temperature and high pressure, and separating the coating from the hot pressing mold and the core rod after solidification to form a urinary catheter body with the shark pattern microstructure.

[0085] The use of a urinary catheter having a shark pattern microstructure manufactured by the manufacturing method provided by the present invention has an additional layer of shark pattern microstructure on the surface of the urinary catheter body, so that the urinary catheter has an antibacterial effect when inserted into the human body for drainage, thereby improving the safety of use; it also has the functions of preventing tissue adhesion and alleviating the pain of the user, thereby solving the problem of poor comfort during use.

[0086] When the core rod used is a core rod with a shark pattern microstructure, a layer of shark pattern microstructure is added to the surface and inner cavity of the catheter body, that is, by adding a layer of micron-level antibacterial texture on the inside and outside of the catheter body, a catheter body with a shark pattern microstructure on both sides is formed, which overcomes the technical difficulties of double-sided transfer of microstructures on a small tube structure in the traditional transfer process and further enhances the antibacterial effect.

[0087] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface, characterized in that: The manufacturing steps include: S1, manufacturing a core rod and a hot pressing mold with a shark pattern microstructure, wherein the hot pressing mold is in a hollow cylindrical shape, and an inner surface of the hot pressing mold has a shark pattern microstructure; S2, coating the surface of the mandrel in step S1; S3, placing the core rod with the coating in step S2 into the hot pressing mold in step S1, and transferring the shark pattern microstructure to the coating in step S2 through high temperature and high pressure; S4, after the transfer is completed, the coating is solidified to form a tube body, the tube body is taken out from the hot pressing mold, and the mandrel is separated from the tube body; That is, a urinary catheter body with a shark pattern microstructure can be obtained.

2. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 1, characterized in that: The step S1 of making the hot pressing mold with shark pattern microstructure also includes the following steps: S11-1, preparing a soft film having a shark-grain microstructure on one side; S11-2, preparing a mold base, wherein the mold base has a semi-cylindrical protrusion arranged longitudinally; S11-3, attaching the smooth side of the soft film having the shark pattern microstructure to the surface of the mold base; S11-4, uniformly forming a metal conductive layer with a thickness of 30-300 nm on the side of the soft film having the shark pattern microstructure; S11-5, thickening the metal conductive layer generated in step S11-4 to 3 mm-20 mm; S11-6, peeling off the metal conductive layer thickened in step S11-5 from the surface of the soft film attached to the surface of the mold base, removing the excess part required for manufacturing the hot pressing mold, and obtaining a half part of the hot pressing mold with a shark pattern microstructure on the inner surface; S11-7, repeating steps S11-1 to S11-6 to obtain the other half of the hot pressing mold having a shark pattern microstructure on the inner surface; By combining the two parts of the hot pressing molds with shark pattern microstructures on the inner surfaces in steps S11-6 and S11-7, a complete hot pressing mold with shark pattern microstructures can be obtained.

3. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 2, characterized in that: The step S11-3 also includes an exhaust treatment process, so that the smooth side of the soft film with shark pattern microstructure is tightly attached to the surface of the mold base, and the exhaust treatment process uses an electrostatic adsorption method, a vacuum adsorption method, an adhesive bonding method, or a substrate hardening method.

4. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 1, characterized in that: When the core rod prepared in step S1 is a core rod having a shark pattern microstructure, the following steps are also included: S12-1, preparing a core rod body, wherein the core rod body has a cylindrical structure; S12-2, coating an adhesion-promoting layer on the outer peripheral surface of the mandrel; S12-3, providing a carrier with a shark pattern microstructure on the surface of the adhesion-promoting layer; S12-4, attaching the shark grain microstructured side of the soft film to the surface of the carrier, and curing the soft film to cure the adhesion-promoting layer and the carrier on the mandrel body, so that the carrier, the adhesion-promoting layer and the mandrel body form a combined body; S12-5, peeling off the soft film, and transferring the shark pattern microstructure of the soft film to the combined body; That is, a core rod with a shark pattern microstructure can be obtained.

5. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 4, characterized in that: In the step S12-2, the adhesion-promoting layer is evenly coated on the core rod body by spraying or curtain coating.

6. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 4, characterized in that: In the step S12-2, the material of the adhesion-enhancing layer is one or more of rosin resin, polyterpene resin, petroleum resin, and phenolic resin, and the thickness is 10-40 um.

7. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 4, characterized in that: In the step S12-3, the material of the carrier is resin or latex, and the thickness is 10-30 um.

8. The method for manufacturing a core rod with a shark pattern microstructure according to claim 4, characterized in that: In step S12-4, the shark pattern microstructure is evenly or unevenly distributed on the entire or partial surface of the carrier.

9. The method for manufacturing a urinary catheter body having a shark pattern microstructure on the surface according to claim 4, characterized in that: In the step S12-4, the curing method is baking curing or UV curing, the baking curing includes baking at 60-90°C for 3 minutes to 10 minutes, and the UV curing process is to cure by a UV lamp with an energy of 100-500mJ.

10. A urinary catheter, comprising a urinary catheter body, characterized in that: The catheter tube body is manufactured by the manufacturing method of the catheter tube body having a shark pattern microstructure on the surface as described in any one of claims 1 to 9.

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